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Transcutaneous Neuromuscular Electrical Stimulation May Be Beneficial in MARK the Treatment of Premature Ejaculation

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Transcutaneous Neuromuscular Electrical Stimulation May Be Beneficial in MARK the Treatment of Premature Ejaculation Medical Hypotheses 109 (2017) 181–183 Contents lists available at ScienceDirect Medical Hypotheses journal homepage: www.elsevier.com/locate/mehy Transcutaneous neuromuscular electrical stimulation may be beneficial in MARK the treatment of premature ejaculation Ilan Gruenwalda, Ege Can Serefoglub, Tal Gollanc, Shmuel Springerd, Gideon Meiryc, Boaz Appela, ⁎ Arik Shechtera,e, a Neurourology Unit, Rambam Healthcare Campus, Haifa, Israel b UroKlinik, Istanbul, Turkey c Virility, Israel d Physical Therapy Department, Faculty of Health Sciences Ariel University, Israel e Department of Family Medicine, Ruth and Bruce Rappaport Faculty of Medicine, Technion Institute of Technology, Clalit Health Services, Haifa, Israel ABSTRACT Approximately 20–30% of sexually active men suffer from Premature Ejaculation (PE), but the pathophysiology still remains unclear and the current available treatments for PE are unsatisfying. Considering the role of rhythmic bulbospongiosus and ischiocavernosus Muscles contractions on the ejaculatory reflex, we hypothesize that weakening this muscles via inhibiting it’s contractions by Application of Neuromuscular Electrical Stimulation prior to the planned sexual activity, may have a beneficial effect in the treatment of PE. Using miniaturized perineal on-demand stimulation device, in a home setting during sexual intercourse may become the first line of treatment for PE. Introduction result of epithelial secretion and smooth muscle cell contraction [7]. All of the organs contributing to emission phase receive a dense autonomic Premature ejaculation (PE) is a very common and disturbing sexual innervation composed of both sympathetic and parasympathetic axons, dysfunction in men, associated with detrimental psychological, physical which are mainly derived from the pelvic plexus. Epididymis, vas de- and social effects. Approximately 20–30% of sexually active men suffer ferens, seminal vesicles, prostate gland, prostatic urethra and bladder from PE (Porst et al., 2007; [1–3]). Although this dysfunction has been neck are all involved in the emission phase [6]. widely investigated, its pathophysiology still remains unclear. Today, Expulsion is a spinal cord reflex, which causes the ejection of sperm there is only one oral compound, which has been specifically developed from the posterior urethra to the meatus. During this phase, smooth for the pharmaceutical treatment of PE, Dapoxetine. Although it has muscle bundles contract in the bladder neck to prevent backflow of been approved by the European Medical Agency (EMEA), Dapoxetine semen into the bladder, and the pelvic floor muscles, with bulbos- has not been approved by the U.S. Food and Drug Administration pongiosus and ischiocavernosus muscles playing major functional roles, (FDA), due to its controversial efficacy and safety (Mondaini et al., display significant rhythmic contractions to propel semen distally, 2013; [4, 5]). Therefore, the treatment of PE continues to be a major throughout the bulbar and penile urethra towards the meatus [8,9]. area of medical research. Definition and pathophysiology of PE Physiology of ejaculation The exact definition, epidemiology, classification and pathophy- From the physiologic point of view, ejaculation has two phases: siology of PE have been dispersed over time [10]. In the recent years, emission and expulsion, which involve several pelvi-perineal anato- there has been some progress in PE research, which resulted in a better mical structures. After a sufficient erotic stimulus, a tight coordination understanding and study of this prevalent condition [11]. Several of sympathetic, parasympathetic and somatic divisions of the nervous professional organizations such as the American Psychiatric Association system is necessary for a normal ante grade ejaculation [6]. (APA) and the International Society for Sexual Medicine (ISSM) have Emission is the ejection of semen into the posterior urethra, as a revised their PE definitions considering the recent evidence pertaining ⁎ Corresponding author. E-mail address: [email protected] (A. Shechter). http://dx.doi.org/10.1016/j.mehy.2017.10.008 Received 20 July 2017; Accepted 7 October 2017 0306-9877/ © 2017 Published by Elsevier Ltd. I. Gruenwald et al. Medical Hypotheses 109 (2017) 181–183 to PE [12,13]. Considering the key elements (time, control and distress) Hypothesis in these evidence-based definitions, PE can be defined as: 1) An eja- culation that occurs at less than 1 min from vaginal penetration (pri- As ejaculation involves rapid stereotyped rhythmic contractions of mary or lifelong PE) or less than 3 min (secondary or acquired PE); and the bulbospongiosus and ischiocavernosus muscles, inhibiting this type 2) ejaculation that cannot be postponed in nearly all attempts with of contractions may have a beneficial effect in the treatment of PE. vaginal penetration; and 3) PE inflicts personal distress with negative When a muscle is continuously stimulated the successive contractions consequences such as avoidance of sexual relations [13]. fuse together resulting in inability of muscle relaxation. Application of It is well accepted in modern sexology, that within reasonable NMES to these muscles prior to the planned sexual activity may keep limits, if a patient experiences dissatisfaction and distress as a result of them in a sub-tetanic sustained contraction for several minutes, which inability to control the timing of orgasm, he is eligible to medical as- may inhibit the natural rhythmic muscle contractions, which is neces- sistance, regardless of his objective latency time. sary for the completion of the ejaculatory process. This intervention The mechanisms, which play role in the pathophysiology of PE, may significantly increase the time to ejaculation in patients with PE. have not yet been completely elucidated. Hyposensitivity and/or hy- However, there are some limitations of our hypothesis. Though the persensitivity of the central serotonin receptors [14], genetic factors carry-over effect (i.e., increased ejaculatory latency time) of NMES to [15], endocrinologic disruptions [16] and some urologic conditions improve the contractile strength of these muscles has been reported [17,18] may be responsible for the hyperactivity of the ejaculation after a repetitive treatment [33], the immediate on-demand effect of reflex. In addition to these organic disorders, psychological problems NMES during sexual intercourse has not been demonstrated yet. Thus, a (e.g. performance anxiety, relationship problems and etc.) may cause well-designed clinical study is necessary to establish this effect. Another acquired PE [19] by activating the sympathetic nervous system and important issue of such study should be to reject the undesirable causing reduced ejaculatory threshold [20]. probability of anejaculation which might be characterized by the ab- sence of ejaculation due to the spastic contraction of these muscles. Furthermore, a technical factor that needs to be considered is the ability Treatment of premature ejaculation of the subject to accurately position the electrodes in the correct place in the perineum in order to achieve the desired outcome of delaying the In the past, the origin of PE was attributed mainly to psychological ejaculation. Hence, future studies should evaluate the effectiveness of factors; nevertheless, possible neurobiological aetiologies were recently this on demand treatment in comparison with other commonly used proposed [21]. These advancements revolutionized the PE treatment treatments. and currently pharmacotherapy is considered as the most effective We believe that the new on-demand application of NMES on the treatment in PE [22]. Until recently only chronic selective serotonin perineum skin may be a viable, efficient and safe treatment option for reuptake inhibitors (SSRIs) confirmed their role as first-line agents with PE, if the efficacy of this therapy will be proven by future studies, we their consistent efficacy in delaying ejaculation [23]. However, only suggest to develop a transcutaneous electrical stimulation miniature Dapoxetine (Priligy, Menarini, Italy), which is a short acting SSRI, has device for the treatment of premature ejaculation. been approved for the treatment of PE [24]. Unfortunately, recent post- marketing studies demonstrated that discontinuation rate of Dapox- Conflict of interests etine is very high [4,25] due to its limited efficacy and side effects [26]. Therefore, several new compounds are being investigated as an alter- Gruenwald Ilan – consultant for Virility Medical, a company that native for PE treatment. intends to develop a device based on this hypothesis. Considering the role of rhythmic bulbospongiosus muscle contrac- Ege Can Serefoglu – consultant for Virility Medical, a company that tions on the ejaculatory reflex, Serefoglu and Silay hypothesized that intends to develop a device based on this hypothesis. weakening this muscle via botulinum toxin injections may delay the Tal Gollan – CEO of Virility Medical, a company that intends to time of ejaculation [27]. In an animal study, botulinum-A toxin injec- develop a device based on this hypothesis. tion into the bulbospongiosus muscle is shown to be effective in ex- Shmuel Springer – consultant for Virility Medical, a company that tending the ejaculatory latency without affecting the ability to engage intends to develop a device based on this hypothesis. in sexual activity or achieve ejaculation [28]. Although clinical studies Gideon Meiry – consultant for Virility Medical, a company that in- which demonstrate
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